The Biden Administration this week cut a $231.8-million deal with Australian Ellume to provide 8.5 million rapid, at-home COVID-19 tests, following FDA emergency authorization in December.
The deal also includes a deal for Ellume with the U.S. Department of Defense to fund a U.S.-based manufacturing plant that hopes to produce more than 500,000 test kits per day.
The Ellume test is available without a prescription and sends results to a smartphone within 15 minutes.
In U.S. clinical trials of adults and children aged 2 and older, the test showed 96% accuracy.
The test relies on a nasal swab sample collection process, which is then placed into a digital analyzer.
In December, upon the closure of clinical trials with successful results in the U.S., the FDA granted emergency authorization for the test to be used by Americans at home.
While Ellume has committed to providing the U.S. with 8.5 million tests, the deliverable will be 100,000 tests per month, for now, from the Australian facility, beginning this month. Once the U.S. facility is built, it will be able to provide up to 19 million tests per month.
Ellume noted that the 8.5 million tests represents “a portion of the overall manufacturing”.
What remains unclear, then, is how 100,000 tests per month will be distributed, and if this is going to be another disastrous vaccine distribution story.
Can consumers buy the test? No. At least not yet. Ellume said we would have to wait for the “coming weeks” to find out about retail plans.
Presently, based on Johns Hopkins data, the average daily testing rate is approximately 550 per 100,000 people.
Some will speculate that the existence of vaccines renders COVID testing irrelevant.
The elephant in the room is this: Vaccines are only very slowly being distributed, and with new variants of the virus arising, controlling the pandemic is becoming increasingly challenging. The ability to test rapidly, and at home is vital.
The deal with Ellume is a good start, but 100,000 test kits a month aren’t enough to regain control.
There have been other tests available to consumers on the market, but none of them rapid. There are even vending machines where COVID tests can be purchased. All of those approved, however, required customers to send in samples for lab analysis.
Those tests have been chaotically distributed, and chaotically received. Results are quick enough, and there is skepticism that it will get any quicker, any time soon.
“The system we have right now — as discontinuous as it is and problematic as it is — it really built up organically, and that’s part of the problem,” former FDA commissioner Dr. Scott Gottlieb told CNBC on Tuesday. “You don’t have an efficiently run system because no one really built this rationally.”
For traders, Ellume is unfortunately a private company, not listed on the ASX (Australian Stock Exchange). Stocks would be soaring otherwise, because Biden has lauded this deal as a “critical way to reopen large parts of America's battered economy” as it deals with what the White House has called a “chicken and egg problem that we have actually taken a step to solve today”.
By Fred Dunkley for Safehaven.com